ABBV 47D11
Alternative Names: 47D11 - AbbVie/Harbor Biomed/Erasmus University Medical Center/University of Utrecht; ABBV-47D11; Anti-coronavirus antibody - AbbVie/Harbor Biomed/Erasmus University Medical Center/University of Utrecht; HBM-9022Latest Information Update: 28 Jan 2024
At a glance
- Originator Erasmus MC; Harbour BioMed; Utrecht University
- Developer AbbVie; Erasmus MC; Harbour BioMed; Utrecht University
- Class Antivirals; Monoclonal antibodies
- Mechanism of Action Virus internalisation inhibitors
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Preclinical COVID 2019 infections
Most Recent Events
- 28 Jan 2024 No recent reports of development identified for phase-I development in COVID-2019-infections(Combination therapy) in Hungary (IV, Infusion)
- 28 Jan 2024 No recent reports of development identified for phase-I development in COVID-2019-infections(Combination therapy) in Israel (IV, Infusion)
- 28 Jan 2024 No recent reports of development identified for phase-I development in COVID-2019-infections(Combination therapy) in Netherlands (IV, Infusion)
Development Overview
Introduction
ABBV 47D11, also known as HBM 9022 is a fully human monoclonal antibody, neutralising the spike proteins of SARS-CoV-2, being jointly developed by AbbVie, Harbor Biomed, Erasmus University Medical Center and University of Utrecht, for the treatment and prevention of SARS-CoV-2 coronavirus (COVID-2019) infections. HBM 9022 is expected to block the attachment of the SARS-CoV-2 coronavirus and is designed to minimise immune-related side effects. Early clinical development is underway in the US, Hungary, Israel, the Netherlands and Puerto Rico. Preclinical development for prevention of COVID-2019 infections is ongoing in the Netherlands.
Harbor Biomed uses patented transgenic mouse platforms (Harbour Mice®) for generating both fully human monoclonal antibodies (H2L2) and heavy chain only antibodies (HCAb) based immune cell engager (HBICETM) bispecific antibodies (Harbor Biomed website, March 2020).
Harbor Biomed is looking for partnership opportunities for further development of antibodies (Harbor Biomed website, March 2020).
As at January 2024, no recent reports of development had been identified for phase-I development in COVID-2019-infections (Combination therapy) in USA (IV, Infusion), Netherlands (IV, Infusion), Hungary (IV, Infusion), Israel (IV, Infusion), Puerto Rico (IV, Infusion), phase-I development in COVID-2019-infections (Monotherapy) in USA (IV, Infusion), Netherlands (IV, Infusion), Hungary (IV, Infusion), Israel (IV, Infusion), Puerto Rico (IV, Infusion).
Company Agreements
In December 2020, Harbour BioMed and Utrecht University entered into a licensing agreement with AbbVie, for their ABBV 47D11 program for the prevention and treatment of COVID-19 and related coronaviruses. Under the terms of the agreement, AbbVie has obtained worldwide rights for development, manufacture, and commercialization of ABBV 47D11. AbbVie will pay Harbour BioMed and Utrecht University a one-time license fee; payments upon achievement of certain development, regulatory and sales-based milestone and tiered royalties on commercial net sales of the antibody. Erasmus MC was involved in the fundamental science but is not involved in the license agreement. Additional terms were not disclosed.
[1]
In June 2020, AbbVie signed a collaboration agreement with Harbour BioMed, Utrecht University and Erasmus Medical Center for the continued preclinical and clinical development of HBM 9022, in the prevention and treatment of COVID-2019 infections. The deal also presented AbbVie with an exclusive option to globally license HBM 9022, for further clinical development and commercialisation. In accordance with the collaboration terms, AbbVie will immediately lend support to Harbour BioMed, Utrecht University and Erasmus Medical Center through preclinical activities, and also assist in preparations for later stage preclinical and clinical development work. [2]
Key Development Milestones
In August 2021, AbbVie completed a phase I trial of ABBV 47D11 and ABBV 2B04 [see Adis profile 800065513] and as monotherapy or combination therapy, to evaluate safety, pharmacokinetics, and pharmacodynamics (single ascending doses), in adults hospitalised with COVID-2019 infections (NCT04644120; EudraCT2020-005203-39; M20-404). The randomised, double-blinded, placebo-controlled study initiated in December 2020 and enrolled 25 participants in the US, Hungary, Israel, the Netherlands and Puerto Rico [1] [3] .
In March 2020, the first human monoclonal antibody (47D11) was identified that binds to cells expressing the full-length spike proteins of SARS-CoV and SARS-CoV-2. Cell culture studies showed that HBM 9022 blocked infection by the SARS-CoV-2 and a second coronavirus SARS-CoV [4] [2] [5] .
Financing information
In July 2020, Harbour BioMed, raised $102.8 million in a Series C financing round. The company intends to use the funds for the development of next generation biologics targeting cancer, immunologic diseases, and COVID-19 [6] .
Drug Properties & Chemical Synopsis
- Route of administration IV
- Formulation Infusion
- Class Antivirals, Monoclonal antibodies
- Target Coronavirus spike glycoprotein; Virus internalisation
- Mechanism of Action Virus internalisation inhibitors
-
WHO ATC code
J05 (Antivirals for Systemic Use)
-
EPhMRA code
J5 (Antivirals for Systemic Use)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Preclinical | Netherlands | IV / Infusion | AbbVie, Utrecht University, Harbour BioMed, Erasmus MC | 12 May 2020 |
| COVID 2019 infections | - | Combination therapy | No development reported (I) | Hungary, Israel, Netherlands, Puerto Rico, USA | IV / Infusion | AbbVie | 28 Jan 2024 |
| COVID 2019 infections | - | Monotherapy | No development reported (I) | Hungary, Israel, Netherlands, Puerto Rico, USA | IV / Infusion | AbbVie | 28 Jan 2024 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Harbour BioMed | Originator | China |
| Erasmus MC | Originator | Netherlands |
| Utrecht University | Originator | Netherlands |
| Utrecht University | Owner | Netherlands |
| Erasmus MC | Owner | Netherlands |
| Harbour BioMed | Owner | China |
| AbbVie | Licensee | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Harbour BioMed | - | Unspecified | - | 23 Mar 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Combination therapy) in Hungary (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Combination therapy) in Israel (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Combination therapy) in Netherlands (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Combination therapy) in Puerto Rico (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Combination therapy) in USA (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Monotherapy) in Hungary (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Monotherapy) in Israel (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Monotherapy) in Netherlands (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Monotherapy) in Puerto Rico (IV, Infusion) Updated 28 Jan 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Monotherapy) in USA (IV, Infusion) Updated 28 Jan 2024 |
| 24 Aug 2021 | Trial Update | AbbVie completes a phase I trial in COVID-2019 infections in USA, Netherlands, Hungary, Israel, Puerto Rico (IV) (NCT04644120) Updated 15 Sep 2021 |
| 15 Dec 2020 | Licensing Status | Harbour BioMed and Utrecht University enters a licensing agreement with AbbVie for ABBV 47D11, for the prevention and treatment of COVID-2019 infections and related coronaviruses [1] Updated 21 Dec 2020 |
| 15 Dec 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Monotherapy) in USA (IV) [1] (NCT04644120) Updated 21 Dec 2020 |
| 10 Dec 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Combination therapy) in USA, Netherlands, Hungary, Israel, Puerto Rico (IV) (NCT04644120) Updated 15 Sep 2021 |
| 10 Dec 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Monotherapy) in Netherlands, Hungary, Israel, Puerto Rico (IV) (NCT04644120) Updated 15 Sep 2021 |
| 25 Nov 2020 | Trial Update | AbbVie plans a phase I trial for COVID-2019 infections in USA (IV) (NCT04644120) Updated 07 Dec 2020 |
| 05 Jun 2020 | Licensing Status | AbbVie collaborates with Harbour BioMed, Utrecht University and Erasmus Medical Center for development of HBM 9022 for COVID-2019 infections (Prevention and treatment) (Parenteral) and acquires exclusive global option for development and commercialisation of HBM 9022 [2] Updated 10 Jun 2020 |
| 05 Jun 2020 | Trial Update | AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center plan preclinical and clinical development in COVID-2019 infections (Prevention and treatment) (Parenteral) [2] Updated 10 Jun 2020 |
| 12 May 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in Netherlands (IV), prior to May 2020 (Harbour BioMed pipeline, May 2020) Updated 12 May 2020 |
| 12 May 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in Netherlands (IV), prior to May 2020 (Harbour BioMed pipeline, May 2020) Updated 12 May 2020 |
| 31 Mar 2020 | Licensing Status | Anti-coronavirus antibodies is available for licensing as of 23 Mar 2020. http://www.harbourbiomed.com/en/partner.html Updated 31 Mar 2020 |
| 23 Mar 2020 | Phase Change | Early research in COVID-2019 infections (Prevention) in Netherlands (Parenteral) before March 2020 [4] Updated 26 Mar 2020 |
| 23 Mar 2020 | Phase Change | Early research in COVID-2019 infections in Netherlands (Parenteral) before March 2019 [4] Updated 26 Mar 2020 |
References
-
Harbour BioMed and Utrecht University AnnounceLicense Agreement with AbbVie and Initiation of COVID-19 Antibody Clinical Trials.
Media Release -
AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center Announce Collaboration to Develop Monoclonal Antibody Therapy to Prevent and Treat COVID-19.
Media Release -
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 and ABBV-2B04 as Monotherapy or Combination Therapy in Adults With COVID-19
ctiprofile -
Human antibody to new coronavirus.
Media Release -
COVID-19-Utrecht University. Internet-Doc 2020;.
Available from: URL: https://www.biorxiv.org/content/10.1101/2020.03.11.987958v1.full.pdf -
Harbour BioMed Raises $102.8M in Series C Financing to Accelerate Development of Its Innovative Portfolio of Next Generation Biologics.
Media Release
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